Probiotic Formula and Infant Growth
ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS
1 other identifier
interventional
N/A
1 country
8
Brief Summary
This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2011
Typical duration for not_applicable healthy
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedNovember 4, 2014
November 1, 2014
1.5 years
November 14, 2011
November 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
growth
weight gain assessed monthly
4 months
Secondary Outcomes (5)
other growth
4 months
adverse events
4 months
stool characteristics
throughout study
spit-up
throughout study
vomit
throughout study
Study Arms (2)
control infant formula
ACTIVE COMPARATORpartially hydrolyzed whey infant formula
test infant formula
EXPERIMENTALpartially hydrolyzed whey infant formula with probiotic
Interventions
partially hydrolyzed whey infant formula consumed ad libitum throughout study
Eligibility Criteria
You may qualify if:
- Healthy newborn infant
- Full-term
- Birth weight \> 2500 and \< 4500 g
- ±3 days of age on enrollment
- Exclusively formula-fed, singleton birth
- Having obtained his/her legal representative's informed consent
You may not qualify if:
- Known or suspected cow-milk allergy
- Congenital illness or malformation that may affect infant feeding and/or growth
- Significant prenatal and/or postnatal disease
- Any readmission to hospital prior to enrollment
- Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
- Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
- Currently participating in another clinical study
- Cannot be expected to comply with treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
North Scottsdale Pediatric Associates
Scottsdale, Arizona, 85258, United States
Pediatrics & Adolescent Medicine
Marietta, Georgia, 30189, United States
Kentucky Pediatric Adult Research
Bardstown, Kentucky, 40004, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
PMG Research of Bristol
Bristol, Tennessee, 37620, United States
Pediatric Healthcare of Northwest Houston
Tomball, Texas, 77375, United States
Advanced Pediatrics
Vienna, Virginia, 22180, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2011
First Posted
November 22, 2011
Study Start
December 1, 2011
Primary Completion
June 1, 2013
Study Completion
October 1, 2013
Last Updated
November 4, 2014
Record last verified: 2014-11